Revised Guideline on requirements for revision/renewal of CEPs: corrected version available

N.B. A corrected version of the guidelines is available where under change 4.II.1.1 c) & e) specific documentation 2 has been deleted and under 4.II.1.2. condition 4 has been deleted since superfluous.

Examples include the introduction of a new substantially different route of synthesis (even when the impurity profile of the final substance is equivalent), unless it replaces the current process, or the addition of a new manufacturing site of the final substance which does not belong to the same group, even when specifications are unchanged (see page 3 for a complete list of these situations).

The EDQM will publish in the near future clarification and the procedures on how to handle separate applications when needed.